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Global Soliris Drug Market 2025-2035

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LSH 25.09.24

Soliris Drug Market Size, Share & Trends Analysis Report by Type (Plasma Exchange and Plasma Infusion), by Application (Paroxysmal Nocturnal Hemoglobinuria (PNH), Atypical Hemolytic Uremic Syndrome (aHUS), Myasthenia Gravis, Neuromyelitis Optica Spectrum Disorder, and Other), Forecast Period (2025-2035)

Industry Overview

Soliris drug market was valued at $2.5 billion in 2024 and is projected to reach $4.3 billion by 2035, growing at a CAGR of 5.2% during the forecast period (2025-2035). Soliris drug (eculizumab) is the medication to treat very rare diseases such as PNH, aHUS, generalized myasthenia gravis, and Neuromyelitis Optica spectrum disorder. The market is driven by growing awareness and diagnosis of rare genetic diseases, with this drug and a few biosimilars being the only treatments for these life-threatening conditions.

Market Dynamics

Rising Genetic Disorders are Increasing the Demand for Soliris Drug Technology

The demand for Soliris is driven by the increasing prevalence of genetic disorders and rare diseases around the globe. According to the World Health Organization (WHO), a rare disease affects approximately 1 in 2,000 individuals in the general population. Currently, there are over 7,000 known rare diseases impacting more than 300 million people globally, with about 70% of these conditions beginning in childhood. Additionally, there are limited resources for research and diagnosis, as well as insufficient investment and financial incentives for drug development in rare diseases. More than 95% of rare diseases still lack an effective treatment, which further supports the development of therapies based on Soliris.

High Treatment Costs and Access Challenges

Soliris faces significant market challenges due to its high cost, with annual treatment expenses exceeding $500,000 per patient. At approximately $6,523 per single-dose vial, Soliris ranks among the world's most expensive medications. This pricing structure creates substantial access barriers, particularly in emerging markets and regions with limited healthcare budgets.

Market Segmentation

  • Based on the type, the market is segmented into plasma exchange and plasma infusion.
  • Based on the application, the market is segmented into paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), myasthenia gravis, neuromyelitis optica spectrum disorder, and other.

Regional Outlook

The global soliris drug market is further divided by region, including North America (the US and Canada), Europe (the UK, Germany, France, Italy, Spain, Russia, and the Rest of Europe), Asia-Pacific (India, China, Japan, South Korea, Australia and New Zealand, ASEAN Countries, and the Rest of Asia-Pacific), and the Rest of the World (the Middle East & Africa, and Latin America).

North America Dominates the Soliris Drug Market

North America maintains the largest market share in the global Soliris drug market. The region continues to dominate the growing Soliris drug ecosystem owing to strong research infrastructure, favorable regulatory environments, large government investment, and major biotechnology and pharmaceutical companies. Also, North America has a high prevalence of rare diseases such as Paroxysmal Nocturnal Hemoglobinuria and atypical Hemolytic Uremic Syndrome, driving demand for the Soliris drug. The region has an established healthcare system, including advanced diagnostic capabilities, which facilitates early detection and treatment of these conditions, contributing to market expansion.

Market Players Outlook

The major companies operating in the global Soliris drug market include Alexion Pharmaceuticals, Inc. (now part of AstraZeneca), Amgen Inc., and Samsung Bioepis Co., Ltd., among others. Market players are leveraging partnerships, collaborations, mergers, and acquisition strategies for business expansion and innovative product development to maintain their market positioning.

Recent Developments

  • In July 2024, the FDA approved Epysqli (eculizumab-aagh), a biosimilar developed by Samsung Bioepis that references Soliris (eculizumab), for the treatment of paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.
  • In May 2024, the FDA approved Bkemv (eculizuamb-aeeb), the first biosimilar to reference Soliris (eculizumab), for the treatment of 2 rare diseases these are PNH and aHUS.

The Report Covers:

  • Market value data analysis of 2024 and forecast to 2035.
  • Annualized market revenues ($ million) for each market segment.
  • Country-wise analysis of major geographical regions.
  • Key companies operating in the global Soliris drug market. Based on the availability of data, information related to new products and relevant news is also available in the report.
  • Analysis of business strategies by identifying the key market segments positioned for strong growth in the future.
  • Analysis of market-entry and market expansion strategies.
  • Competitive strategies by identifying 'who-stands-where' in the market.

Table of Contents

1. Report Summary

  • Current Industry Analysis and Growth Potential Outlook
  • Global Soliris Drug Market Sales Analysis - Type | Application ($ Million)
  • Soliris Drug Market Sales Performance of Top Countries
  • 1.1. Research Methodology
  • Primary Research Approach
  • Secondary Research Approach
  • 1.2. Market Snapshot

2. Market Overview and Insights

  • 2.1. Scope of the Study
  • 2.2. Analyst Insight & Current Market Trends
    • 2.2.1. Key Soliris Drug Market Trends
    • 2.2.2. Market Recommendations

3. Market Determinants

  • 3.1. Market Drivers
    • 3.1.1. Drivers For the Global Soliris Drug Market: Impact Analysis
  • 3.2. Market Pain Points and Challenges
    • 3.2.1. Restraints For the Global Soliris Drug Market: Impact Analysis
  • 3.3. Market Opportunities
    • 3.3.1. Opportunities For the Global Soliris Drug Market: Impact Analysis

4. Competitive Landscape

  • 4.1. Competitive Dashboard - Soliris Drug Market Revenue and Share by Manufacturers
  • Soliris Drug Product Comparison Analysis
  • Top Market Player Ranking Matrix
  • 4.2. Key Company Analysis
    • 4.2.1. Alexion Pharmaceuticals, Inc. (now part of AstraZeneca)
      • 4.2.1.1. Overview
      • 4.2.1.2. Product Portfolio
      • 4.2.1.3. Financial Analysis (Subject to Data Availability)
      • 4.2.1.4. SWOT Analysis
      • 4.2.1.5. Business Strategy
    • 4.2.2. Amgen Inc.
      • 4.2.2.1. Overview
      • 4.2.2.2. Product Portfolio
      • 4.2.2.3. Financial Analysis (Subject to Data Availability)
      • 4.2.2.4. SWOT Analysis
      • 4.2.2.5. Business Strategy
    • 4.2.3. Samsung Bioepis Co., Ltd.
      • 4.2.3.1. Overview
      • 4.2.3.2. Product Portfolio
      • 4.2.3.3. Financial Analysis (Subject to Data Availability)
      • 4.2.3.4. SWOT Analysis
      • 4.2.3.5. Business Strategy
  • 4.3. Top Winning Strategies by Market Players
    • 4.3.1. Merger and Acquisition
    • 4.3.2. Product Launch
    • 4.3.3. Partnership And Collaboration

5. Global Soliris Drug Market Sales Analysis by Type ($ Million)

  • 5.1. Plasma Exchange
  • 5.2. Plasma Infusion

6. Global Soliris Drug Market Sales Analysis by Application ($ Million)

  • 6.1. Paroxysmal Nocturnal Hemoglobinuria (PNH)
  • 6.2. Atypical Hemolytic Uremic Syndrome (aHUS)
  • 6.3. Myasthenia Gravis
  • 6.4. Neuromyelitis Optica Spectrum Disorder
  • 6.5. Other

7. Regional Analysis

  • 7.1. North American Soliris Drug Market Sales Analysis - Type | Application ($ Million)
  • Macroeconomic Factors for North America
    • 7.1.1. United States
    • 7.1.2. Canada
  • 7.2. European Soliris Drug Market Sales Analysis - Type | Application ($ Million)
  • Macroeconomic Factors for Europe
    • 7.2.1. UK
    • 7.2.2. Germany
    • 7.2.3. Italy
    • 7.2.4. Spain
    • 7.2.5. France
    • 7.2.6. Russia
    • 7.2.7. Rest of Europe
  • 7.3. Asia-Pacific Soliris Drug Market Sales Analysis - Type | Application ($ Million)
  • Macroeconomic Factors for Asia-Pacific
    • 7.3.1. China
    • 7.3.2. Japan
    • 7.3.3. South Korea
    • 7.3.4. India
    • 7.3.5. Australia & New Zealand
    • 7.3.6. ASEAN Countries (Thailand, Indonesia, Vietnam, Singapore, And Other)
    • 7.3.7. Rest of Asia-Pacific
  • 7.4. Rest of the World Soliris Drug Market Sales Analysis - Type | Application ($ Million)
  • Macroeconomic Factors for the Rest of the World
    • 7.4.1. Latin America
    • 7.4.2. Middle East and Africa
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